Predicting Treatment Outcomes With Intensive Outpatient Treatment for PTSD

NCT04307498 | Completed DMC

• 1 other identifier: HSC20190788H
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The open-label clinical study explores potential modifiable predictors of treatment outcomes in a sample of 55 military service members and veterans with clinically significant PTSD symptoms who receive Intensive Outpatient Prolonged Exposure (IOP-PE).

Conditions

Posttraumatic Stress Disorder

Keywords

Military; Veteran; Prolonged Exposure; Intensive Outpatient

Outcome Measures

Primary Outcomes (1)

• PTSD Symptoms

  Change in scale measurements by the Clinician Administered PTSD Scale (CAPS-5). The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms)

  Baseline and 1 month follow-up

Study Arms (1)

Intensive Outpatient Program - Prolonged Exposure

OTHER

Participants will complete fifteen weekday 90-minute Prolonged Exposure therapy sessions over three consecutive weeks plus seven augmentations designed to maximize treatment outcomes. If necessary, the treatment window may be extended for another week.

Behavioral: Intensive Outpatient Program - Prolonged Exposure

Interventions

Intensive Outpatient Program - Prolonged Exposure BEHAVIORAL

Prolonged Exposure for Posttraumatic Stress Disorder (PE for PTSD; Foa, Hembree, \& Rothbaum, 2007) is an empirically supported behavioral therapy that utilizes exposure-based interventions to target the psychological mechanisms (i.e., avoidance; maladaptive cognitive changes) thought to maintain trauma-related symptoms. IOP-PE includes 15 days of PE treatment delivered over three consecutive weeks. The standard outpatient PE protocol has modified with seven treatment augmentations to meet the unique needs of post-9/11 veterans.

Also known as: IOP-PE

Intensive Outpatient Program - Prolonged Exposure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active duty military service members or veterans (18 years or older) who were impacted by Hurricane Harvey.
• Significant PTSD symptoms as measured by a Posttraumatic Stress Disorder Checklist (PCL-5) score of 34 or higher.
• Able to speak and read English (due to standardization of outcome measures)
• Able to participate in a three-week intensive outpatient program

You may not qualify if:

• Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by the bipolar and psychosis modules of the Mini International Neuropsychiatric Interview (MINI) and clinical judgment)
• Current and severe alcohol use warranting immediate intervention based on clinical judgment.
• Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
• Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider.
• Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• The Robert W. Woodruff Foundation: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• Peterson AL, Foa EB, Blount TH, McLean CP, Shah DV, Young-McCaughan S, Litz BT, Schobitz RP, Castillo DT, Rentz TO, Yarvis JS, Dondanville KA, Fina BA, Hall-Clark BN, Brown LA, DeBeer BR, Jacoby VM, Hancock AK, Williamson DE, Evans WR, Synett S, Straud C, Hansen HR, Meyer EC, Javors MA, Sharrieff AM, Lara-Ruiz J, Koch LM, Roache JD, Mintz J, Keane TM; Consortium to Alleviate PTSD. Intensive prolonged exposure therapy for combat-related posttraumatic stress disorder: Design and methodology of a randomized clinical trial. Contemp Clin Trials. 2018 Sep;72:126-136. doi: 10.1016/j.cct.2018.07.016. Epub 2018 Jul 25.

  PMID: 30055335 BACKGROUND

• Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.

  PMID: 29362795 BACKGROUND

Related Links

• STRONG STAR website

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Alan Peterson, PhD, ABPP

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This is a prospective, one-group, exploratory clinical study.

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: November 26, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 22, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)